Recall Z-1377-2008 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal surgery.
| Date | Aug 19, 2008 (initiated Feb 19, 2008) |
| Status | Terminated |
| Reason | The t-bar of the Radius Rod Persuader devices froze due to a loosening screw causing the device to fail. |
| Root cause | Device Design |
| Action | Recall notification was sent via FedEx on February 19, 2008 to all branches/agencies. All questions are to be directed to Michelle Klein, Regulatory Compliance Specialist - 201-760-8256. |
| Quantity | 65 units |
| Distribution | Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.